Physical Medicine Devices; Reclassification and Renaming of Shortwave Diathermy for All Other Uses
Information
Type
Proposed Rule
Regulated products
Published
February 20, 2014
Last updated
February 20, 2014
Description
Document number 2014-03594. The Food and Drug Administration (FDA) is proposing to reclassify the shortwave diathermy (SWD) for all other uses, a preamendments class III device, into class II (special controls), and to rename the device "nonthermal shortwave therapy (SWT)." FDA is proposing this reclassification on its own initiative based on new information. FDA is also proposing a technical correction in the regulation for the carrier frequency for SWD and nonthermal SWT devices. This proposed action would implement certain regulatory requirements.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)